Skip to main content
OpenTrials
Completed

NCT Number: NCT03920982

Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients.

The development of acute kidney injury (AKI) during septic shock is frequent and is associated with a high mortality rate. The reason of this increased mortality despite the use of renal replacement therapy is still unknown. The deleterious effects of uremic toxins (solutes accumulating with the loss of kidney function) has risen for the last decade in chronic kidney disease patients. Among those solutes, indoxyl sulfate (IS) is associated with the development of cardiovascular complications and impairment of immune response. The role of uremic toxins and particularly IS in the prognostic of septic kidney injury is unknown. The investigators propose to analyze the relation between the serum concentration of IS and the mortality of patients hospitalized for a septic shock who developed an AKI.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Mortality Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Toxemia Uremic; Toxemia Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80000, France

About this study

During chronic kidney disease the uremic toxins have been widely described as potential harmful solutes targeting the cardiovascular system, immunologic system, endothelium and bone metabolism. However, nothing is known about the potential accumulation and pejorative effects of those uremic toxins during AKI (Acute Kidney Injury). The objective of this study is to explore the role of the uremic toxins and specially IS (Indoxyl Sulfate) in the mortality of patients hospitalized for a septic shock and AKI. This study will also describe for the first time the kinetic of the blood concentration of different uremic toxins and their relation with the mortality and the kidney function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years hospitalized in the medical intensive care unit in Amiens university hospital
  • Presence of a septic shock (sepsis associated with a persistent hypotension after fluid resuscitation and requiring vasopressors to maintain MAP > 65 mmHg and/or serum lactate level > 2 mmol/ L).
  • Evidence of AKI (KDIGO > or equal1) in the 72 hours following the admission in the ICU: diuresis < 0.5ml / kg / h for 6 to12 hours or > or equal 1.5 to1.9 fold increase or > 26.5 micromol / l in serum creatinine from baseline
  • signed written informed consent form
  • covered by national health insurance

Exclusion criteria

  • known pre hospitalization (in the last 3 month preceding the hospitalization) advanced chronic kidney disease defined by an estimated glomerular filtration rate < 60 ml / min / 1.73m square
  • Pregnancy
  • Presence or strong clinical suspicion of renal obstruction
  • Moribund patients (expected life < 48h)
  • Cardio respiratory arrest
  • Hemoglobin level below 10 g / dl

Treatment and study plan

Determination of the blood concentration of indoxyl sulfate (IS)

Diagnostic Test

IS concentration will be determined in blood of patients with septic shock and acute kidney injury. IS blood concentration will be done every day during 7 first days after patient will be admitted in intensive care unit. Relation between IS peak serum concentration and mortality at day 28 will be determined.

Primary outcomes

  1. Mortality rate

    Time frame: at day 28 after patient was admitted in intensive care unit

    Mortality of patients hospitalized for a septic shock who developed an acute kidney injury

  2. Mortality rate

    Time frame: at day 90 after patient was admitted in intensive care unit

    Mortality of patients hospitalized for a septic shock who developed an acute kidney injury

Secondary outcomes

  1. Blood concentration of indoxyl sulfate

    Time frame: at day 1 after patient was admitted in intensive care unit

    Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  2. Blood concentration of indoxyl sulfate

    Time frame: at day 2 after patient was admitted in intensive care unit

    Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  3. Blood concentration of indoxyl sulfate

    Time frame: at day 3 after patient was admitted in intensive care unit

    Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  4. Blood concentration of indoxyl sulfate

    Time frame: at day 4 after patient was admitted in intensive care unit

    Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  5. Blood concentration of indoxyl sulfate

    Time frame: at day 5 after patient was admitted in intensive care unit

    Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  6. Blood concentration of indoxyl sulfate

    Time frame: at day 6 after patient was admitted in intensive care unit

    Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  7. Blood concentration of indoxyl sulfate

    Time frame: at day 7 after patient was admitted in intensive care unit

    Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  8. Blood concentration of para cresyl sulfate (PRS)

    Time frame: at day 1 after patient was admitted in intensive care unit

    Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  9. Blood concentration of para cresyl sulfate (PRS)

    Time frame: at day 2 after patient was admitted in intensive care unit

    Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  10. Blood concentration of para cresyl sulfate (PRS)

    Time frame: at day 3 after patient was admitted in intensive care unit

    Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  11. Blood concentration of para cresyl sulfate (PRS)

    Time frame: at day 4 after patient was admitted in intensive care unit

    Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  12. Blood concentration of para cresyl sulfate (PRS)

    Time frame: at day 5 after patient was admitted in intensive care unit

    Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  13. Blood concentration of para cresyl sulfate (PRS)

    Time frame: at day 6 after patient was admitted in intensive care unit

    Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  14. Blood concentration of para cresyl sulfate (PRS)

    Time frame: at day 7 after patient was admitted in intensive care unit

    Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  15. Blood concentration of FGF 23 (Fibroblast Growth Factor 23)

    Time frame: at day 1 after patient was admitted in intensive care unit

    Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  16. Blood concentration of FGF 23 (Fibroblast Growth Factor 23)

    Time frame: at day 2 after patient was admitted in intensive care unit

    Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  17. Blood concentration of FGF 23 (Fibroblast Growth Factor 23)

    Time frame: at day 3 after patient was admitted in intensive care unit

    Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  18. Blood concentration of FGF 23 (Fibroblast Growth Factor 23)

    Time frame: at day 4 after patient was admitted in intensive care unit

    Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  19. Blood concentration of FGF 23 (Fibroblast Growth Factor 23)

    Time frame: at day 5 after patient was admitted in intensive care unit

    Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  20. Blood concentration of FGF 23 (Fibroblast Growth Factor 23)

    Time frame: at day 6 after patient was admitted in intensive care unit

    Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  21. Blood concentration of FGF 23 (Fibroblast Growth Factor 23)

    Time frame: at day 7 after patient was admitted in intensive care unit

    Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  22. Blood concentration of Klotho

    Time frame: at day 1 after patient was admitted in intensive care unit

    Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  23. Blood concentration of Klotho

    Time frame: at day 2 after patient was admitted in intensive care unit

    Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  24. Blood concentration of Klotho

    Time frame: at day 3 after patient was admitted in intensive care unit

    Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  25. Blood concentration of Klotho

    Time frame: at day 4 after patient was admitted in intensive care unit

    Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  26. Blood concentration of Klotho

    Time frame: at day 5 after patient was admitted in intensive care unit

    Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  27. Blood concentration of Klotho

    Time frame: at day 6 after patient was admitted in intensive care unit

    Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

  28. Blood concentration of Klotho

    Time frame: at day 7 after patient was admitted in intensive care unit

    Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Determination of the Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients: TOX-AKI Study

Acronym: TOX-AKI

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2019
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.